Qualifications Required for Position
Possess a minimum 6 years medical device regulatory affairs experience.
Experience in effective interaction with manufacturing, quality, clinical/medical and marketing departments.
FDA Class I and Class II regulatory experience, (21 CFR, Part 820).
· A working knowledge of FDA and regulations and how to interpret and monitor updates with
experience or knowledge in US Title 21 CFR, Part 820
· Thorough understanding of Class I Design Controls
Prior 510(k) experience.
Experience with international regulations, particularly ISO 13485.
Demonstrated experience in project management and FDA medical device documentation.
Demonstrated ability to work effectively in a highly charged, fluid environment.
Demonstrated ability to independently manage multiple projects.
Very detail-oriented, well-organized and driven to meet deadlines and program goals.
Strong verbal and written communication skills, including the ability to make effective and persuasive presentations.
Good computer skills with knowledge of Microsoft Office.
Some domestic and international travel required (10-15%)
Bachelor’s degree in related field or equivalent experience
Previous supervisory experience.
Demonstrated working knowledge of engineering principles.
· Compliance Project Leader from inception to launch of medical device.
· International product launch.
Gorbel Medical is a division of Gorbel, Inc. based in Victor, New York. We have entered the physical rehabilitation space with a Class I exempt device for the physical rehabilitation space. We are enthusiastic individuals with entrepreneurial spirits who are dedicated to improving people’s lives in a collaborative, fun fast paced environment.
Mecical device regulatory affairs: 6 years